Cleared Traditional

K201549 - Motex Anti-Fog Surgical Face Mask

K201549 is the FDA 510(k) clearance for Motex Anti-Fog Surgical Face Mask by Modern Healthcare Corp.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K201549 · Modern Healthcare Corp. · General Hospital
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Aug 2020
Decision
78d
Days
Class 2
Risk

K201549 is an FDA 510(k) clearance for the Motex Anti-Fog Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Modern Healthcare Corp. (Tien-Chung Town, Chang-Hwa County, TW). The FDA issued a Cleared decision on August 26, 2020 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Modern Healthcare Corp. devices

Submission Details

510(k) Number K201549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date August 26, 2020
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Chinese European Industrial Research Society
Ke-Min Jen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 433
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